BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3243950 · Received July 23, 2013

    Report

    Report Number
    2031527-2013-00172
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND THEREFORE, DEVICE EVALUATION COULD NOT BE PERFORMED. COMPUTED TOMOGRAPHY IMAGING AND MEDICAL RECORDS WERE PROVIDED FOR CLINICAL ASSESSMENT. IT APPEARED THAT THE SUPRARENAL AORTIC EXTENSION HAD MIGRATED APPROXIMATELY 2CM DISTALLY, CREATING A KINK IN THE MID PORTION OF THE ENDOGRAFT. THE CAUSE OF THE MIGRATION IS LIKELY ATTRIBUTED TO THE ANGLE OF THE AORTA AND ITS CHANGE IN MORPHOLOGY. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 14 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A PROXIMAL SUPRARENAL AORTIC EXTENSION AND A LIMB EXTENSION, A COMPUTED TOMOGRAPHY SCAN IDENTIFIED OVERLAP BETWEEN THE BIFURCATED DEVICE AND THE PROXIMAL SUPRARENAL AORTIC EXTENSION HAD REDUCED TO APPROXIMATELY 20MM. REPORTEDLY, A KINK AT THE DISTAL END OF THE SUPRARENAL AORTIC EXTENSION WAS ALSO OBSERVED. THE PATIENT WAS TREATED WITH A PROXIMAL INFRARENAL AORTIC EXTENSION BETWEEN THE BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION TO CORRECT THE OVERLAP AND KINK BETWEEN THE DEVICES. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344238 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C95-O20 W11-4311-021

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention